Method and apparatus for enabling data communication between an implantable medical device and a patient management system

ABSTRACT

Embodiments of the invention provide methods, systems, and devices for enabling data communication between an IMD and a host computer. In one embodiment, a device is provided that comprises a frequency and protocol agile transceiver capable of communicating with an IMD via a first communications link and with a host computer via a second wireless communications link, wherein the first wireless communication link is configured for substantially shorter communication range than the second wireless communication link. An apparatus is provided according to another embodiment of the invention that comprises an interface between an IMD and a communications device, such as a wireless telephone or a two-way wireless pager. The interface can communicate directly with the IMD to retrieve clinical data stored in the IMD and can utilize the communications device to transmit the clinical data to a host computer.

RELATED PATENT DOCUMENTS

This application is a continuation of U.S. application Ser. No.11/538,192, filed on Oct. 3, 2006, which is a continuation of U.S.application Ser. No. 10/328,653, filed on Dec. 23, 2002, now U.S. Pat.No. 7,127,300, each of which is incorporated herein by reference.

TECHNICAL FIELD

This application relates generally to patient management systems, andparticularly, but not by way of limitation, to an interface device forcoupling an implantable medical device to a host computer utilized in apatient management system.

BACKGROUND OF THE INVENTION

Management of patients with chronic disease consumes a significantproportion of the total health care expenditure in the United States.Many of these diseases are widely prevalent and have significant annualincidences as well. Heart Failure prevalence alone is estimated at over5.5 million patients in 2000 with incidence rates of over half a millionadditional patients annually, resulting in a total health care burden inexcess of $20 billion. Heart Failure, like many other chronic diseasessuch as Asthma, Chronic Obstructive Pulmonary Disease (“COPD”), ChronicPain, and Epilepsy is event driven, where acute de-compensations resultin hospitalization. In addition to causing considerable physical andemotional trauma to the patient and family, event drivenhospitalizations consume a majority of the total health care expenditureallocated to the treatment of heart failure.

An interesting fact about the treatment of acute de-compensation is thathospitalization and treatment occurs after the event (de-compensation)has happened. However, most Heart Failure patients exhibit priornon-traumatic symptoms, such as steady weight gain, in the weeks or daysprior to the de-compensation. If the attending physician is made awareof these symptoms, it is possible to intervene before the event, atsubstantially less cost to the patient and the health care system.Intervention is usually in the form of a re-titration of the patient'sdrug cocktail, reinforcement of the patient's compliance with theprescribed drug regimen, or acute changes to the patient's diet andexercise regimens. Such intervention is usually effective in preventingthe de-compensation episode and thus avoiding hospitalization.

In order to provide early detection of symptoms that may signal anincreased likelihood of a traumatic medical event, patients may receiveimplantable medical devices (“IMDs”) that have the ability to measurevarious body characteristics. For instance, IMDs are currently availablethat provide direct measurement of electrical cardiac activity, physicalmotion, temperature, and other clinical parameters. The data collectedby these devices is typically retrieved from the device throughinterrogation.

Some IMDs communicate with a repeater located in the patient's home viaa short range wireless communications link. The repeater interrogatesthe IMD and retrieves the clinical data stored within the IMD. Therepeater then establishes a connection with a host computer or patientmanagement system and transmits the clinical data.

While the use of a repeater is convenient for a patient while locatednear the repeater, no data can be transmitted from the IMD to therepeater if the IMD is out of range. Therefore, if the patient is awayfrom home, no data can be communicated to the host computer system viathe repeater. This can be extremely inconvenient, and even dangerous,for the patient if a medically significant event occurs while the IMD isout of range of the repeater.

Therefore, in light of the above, there is a need for a method andapparatus for enabling data communication between an IMD and a hostcomputer that enables communication between the IMD and the hostcomputer in a manner that does not require proximity to a fixed repeaterdevice. There is a further need for a method and apparatus for enablingdata communication between an IMD and a host computer that utilizes aportable communications device for directly communicating with the hostcomputer.

SUMMARY OF THE INVENTION

Embodiments of the present invention solve the above-described problemsby providing a method and apparatus for enabling communication betweenan IMD and a host computer that do not require the use of a fixedlocation repeater device. Embodiments of the present invention alsosolve the above-described problems by enabling communication between anIMD and a host computer in a manner that utilizes a portable wirelesscommunications device that can establish a data connection with the hostcomputer directly through a long range wireless communications link.

According to one actual embodiment of the present invention, anapparatus is provided for enabling communication between an IMD and ahost computer operated as a part of a patient management system. Theapparatus comprises a frequency and protocol agile transceiver capableof configuring itself for communication with the IMD via a short rangewireless communications link and for communication with a host computervia a long range wireless communications link, such as through thewireless telephone network.

The apparatus provided according to one embodiment of the invention alsocomprises a central processing unit (“CPU”), a memory, and a programcapable of configuring the transceiver for communication with the IMD,communicating with the IMD to retrieve clinically significant datastored in the IMD, and of storing the clinical data in the memory. Theprogram is also capable of reconfiguring the transceiver for datacommunication with the host computer via the long range wirelesscommunications link. Once the transceiver has been configured forcommunication with the host computer via the long range wirelesscommunications link, the program transmits the clinical data stored inmemory to the host computer.

According to another actual embodiment of the present invention, anapparatus is provided that comprises an interface between an IMD and acommunications device, such as a wireless telephone or a two-waywireless pager. In particular, the apparatus comprises a transceivercapable of communicating with an IMD via a short range wirelesscommunications link and an input/output interface for communicating withthe communications device. Through the transceiver the apparatus cancommunicate with the IMD and retrieve clinical data stored within theIMD. The apparatus is also operative to establish a communications linkwith a host computer through the communications device. Once such acommunications link has been established, the apparatus can transmit theclinical data to the host computer.

Embodiments of the present invention also include methods and systemsfor enabling communication between an IMD and a patient managementsystem. These and various other features as well as advantages, whichcharacterize the present invention, will be apparent from a reading ofthe following detailed description and a review of the associateddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsdescribe substantially similar components throughout the several views.Like numerals having different letter suffixes represent differentinstances of substantially similar components. The drawings illustrategenerally, by way of example, but not by way of limitation, variousembodiments discussed in the present document.

FIGS. 1A and 1B are block diagrams showing the operation of severalembodiments of the present invention in an illustrative operatingenvironment;

FIG. 2 is a block diagram illustrating an advanced patient managementsystem utilized in one embodiment of the present invention;

FIG. 3 is a block diagram illustrating a computer system utilized invarious embodiments of the present invention;

FIG. 4A is a block diagram illustrating an exampleinterrogator/transceiver unit provided by one embodiment of the presentinvention;

FIG. 4B is a block diagram showing a communication system utilized inone embodiment of the present invention;

FIG. 5 is a block diagram showing a hardware architecture for anapparatus for enabling data communication between an IMD and a hostcomputer provided according to one actual embodiment of the presentinvention;

FIG. 6 is a state diagram illustrating a method for enabling datacommunication between an IMD and a host computer provided in oneembodiment of the present invention;

FIG. 7 is a block diagram showing a hardware architecture for aninterface between an IMD and a communications device provided in oneembodiment of the present invention; and

FIG. 8 is a state diagram illustrating aspects of a method for enablingcommunication between an IMD and a host computer provided according toone embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments or examples. These embodimentsmay be combined, other embodiments may be utilized, and structural,logical, and electrical changes may be made without departing from thespirit and scope of the present invention. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present invention is defined by the appended claims andtheir equivalents.

The apparatus and methods described herein are described in the contextof a patient management system that provides patient management anddevice management. As used herein, the phrase “patient management”refers to the process of creating and collecting patient specificinformation, storing and collating the information, and generatingactionable recommendations to enable the predictive management ofpatients with chronic disease. As used herein, the phrase “devicemanagement’ refers to the process of leveraging a remote communicationsinfrastructure to provide automatic device follow-ups to collect data,provide therapy, and to determine if remote devices are functioningproperly. It should be appreciated that although the embodiments of theinvention are described in the context of a patient management system,the embodiments of the invention may be utilized within other operatingenvironments. Additional details regarding the patient management systemthat provides one operating environment for the embodiments of theinvention are provided below with respect to FIGS. 2-4B. Additionaldetails regarding the apparatus provided herein are provided below withrespect to FIGS. 1A-1B and 5-8.

Turning now to FIG. 1A, one embodiment of the present invention will bedescribed in the context of an illustrative operating environment. Asshown in FIG. 1A, an interface device 99 is provided for enablingcommunication between an IMD 100 and a host computer 200. According tothis embodiment, the interface device 99 is capable of communicatingwith the host computer 200 through a wireless telephone network 108. Inparticular, the interface device 99 is capable of establishing a longrange communications link 104 with a wireless network 108 through awireless tower 106. The data connection is established through a mobiletelephone switching office (“MTSO”) 110. A network gateway 112 may alsobe utilized within the wireless telephone network 108 to enablecommunication with a wide area network 114 (“WAN”). In the actualembodiment of the present invention described herein, the WAN 114comprises the Internet. However, other types of WANs known to thoseskilled in the art may be utilized. In this manner, the interface device99 can establish a digital data connection with host computer 200through the wireless telephone network 108 in the same way that atraditional cellular telephone would establish such a connection.

As shown in FIG. 1A, the IMD 100 may be implanted within a patient 102.The IMD 100 has the ability to sense and communicate and may include theability to provide therapy. In particular, the IMD 100 includes a sensorthat allows it to directly measure characteristics of the patient'sbody. This may include monitoring electrical cardiac activity, physicalmotion, temperature, heart rate, activity, blood pressure, breathingpatterns, wedge-pressure, ejection fractions, blood viscosity, bloodchemistry, blood glucose levels, or other patient specific clinicalparameters without any patient compliance. The measured clinical datamay be stored in a memory of the IMD 100. The IMD 100 also includes awireless transmitter/receiver unit capable of communicating with theinterface device 99 via a short range wireless communications link 103,such as BLUETOOTH, IEEE 802.11b, or other type of short range wirelesscommunications link.

Through the interface device 99, clinical data stored within the IMD 100can be transmitted to the host computer 200. Status informationregarding operation of the IMD 100 may also be sent and software orfirmware updates and configuration changes may be received from the hostcomputer 200. As will be described in greater detail below with respectto FIGS. 2-4B, the host computer 200 performs a variety of functionswithin a patient management system in addition to communicating with theIMD 100.

According to the embodiment of the present invention shown in FIG. 1A,the interface device 99 comprises a wireless digital telephone modifiedfor communication with the IMD 100 and for performing other functionsdescribed herein. However, it should be appreciated by those skilled inthe art that other types of wireless communication devices may bemodified in a similar manner and utilized for communication with the IMD100 and the host computer 200. For instance, a two-way wireless pagermay be similarly modified to communicate with the IMD 100 and tocommunicate with the host computer 200. Other types of wireless devicesmay be modified and utilized similarly to facilitate communicating overa variety of pervasive wireless communication network types. Additionaldetails regarding the hardware architecture and operation of theinterface device 99 according to this embodiment of the invention willbe described below with reference to FIGS. 5 and 6, respectively.

Referring now to FIG. 1B, another embodiment of the present inventionwill be described. As shown in FIG. 1B, this embodiment of the inventionprovides an interface device 105 that is capable of communicating withthe IMD 100 via a short range communications link 103. As describedabove, the short range communications link 103 may comprise a BLUETOOTH,IEEE 802.11b, or other type of short range wireless connection. Theinterface device 105 is also capable of communicating with the hostcomputer 200 via a communications device 107 and a long rangecommunications link 104.

In the embodiment of the present invention shown in FIG. 1B, thecommunications device 107 comprises a conventional digital wirelesstelephone. According to this embodiment, communication is establishedbetween the interface device 105 and the host computer 200 via thecommunications device 107, the wireless tower 106, the MTSO 110, thegateway 112, and the WAN 114. However, it should be appreciated by thoseskilled in the art that other types of wireless communications devicesand other types of communication networks may also be utilized, such asa wireless two-way paging network and the like. Additional detailsregarding the hardware configuration and operation of the interfacedevice 105 will be provided below with reference to FIGS. 7 and 8,respectively.

FIG. 2 illustrates an example advanced patient management system 200made in accordance with the present invention. The advanced patientmanagement system 200 can generally include the following components:one or more devices 202, 204, and 206, one or moreinterrogator/transceiver units 208, a communications system 210, one ormore remote peripheral devices 209, and a host 212.

Each component of the advanced patient management system 200 cancommunicate using the communications system 210. Some components mayalso communicate directly with one another. For example, devices 202 and204 may be configured to communicate directly with one another. Thevarious components of the example advanced patient management system 200illustrated herein are described below.

Devices 202, 204, and 206 can be implantable devices or external devicesthat may provide one or more of the following functions with respect toa patient: (1) sensing, (2) data analysis, and (3) therapy. For example,in one embodiment, devices 202, 204, and 206 can be implanted orexternal devices used to measure a variety of physiological, subjective,and environmental conditions of a patient using electrical, mechanical,and/or chemical means. The devices 202, 204, and 206 can be configuredto automatically gather data or can require manual intervention by thepatient. The devices 202, 204, and 206 can be configured to store datarelated to the physiological and/or subjective measurements and/ortransmit the data to the communications system 210 using a variety ofmethods, described in detail below. Although three devices 202, 204, and206 are illustrated in the example embodiment shown, more or fewerdevices may be used for a given patient.

The devices 202, 204, and 206 can be configured to analyze the measureddata and act upon the analyzed data. For example, the devices 202, 204,and 206 may be configured to modify therapy or provide alarm indicationsbased on the analysis of the data.

In one embodiment, devices 202, 204, and 206 may also provide therapy.Therapy can be provided automatically or in response to an externalcommunication. Devices 202, 204, and 206 can be programmable in that thecharacteristics of their sensing (e.g., duration and interval), therapy,or communication can be altered via communication between the devices202, 204, and 206 and other components of the advanced patientmanagement system 200. Devices 202, 204, and 206 can also performself-checks or be interrogated by the communications system 210 toverify that the devices are functioning properly. Examples of differentembodiments of the devices 202, 204, and 206 are provided below.

Devices implanted within the body have the ability to sense andcommunicate as well as to provide therapy. Implantable devices canprovide direct measurement of characteristics of the body, including,without limitation, electrical cardiac activity (e.g., a pacemaker,cardiac resynchronization management device, defibrillator, etc.),physical motion, temperature, heart rate, activity, blood pressure,breathing patterns, ejection fractions, blood viscosity, bloodchemistry, blood glucose levels, and other patient-specific clinicalphysiological parameters, while minimizing the need for patientcompliance.

A heart rhythm sensor, typically found in a pacemaker or defibrillator,is one example of implantable device. In the heart, an electrical waveactivates the heart muscle just prior to contraction. As is known in theart, electrical circuits and lead-wires transduce the heart's activationevent and reject other, non-essential electrical events. By measuringthe time interval between activation events, the heart rhythm can bedetermined. A transthoracic impedance sensor is another example of animplantable device. During the respiratory cycle, large volumes of airpass into and out of the body. The electrical resistance of the thoraxchanges markedly as a result of large differences in conductivity of airand body tissues. The thoracic resistance can be measured duringrespiration and converted into a measurable electrical signal (i.e.,impedance) so that breathing rate and profile can be approximated.Implantable devices can also sense chemical conditions, such as glucoselevels, blood oxygen levels, etc. Further, the advanced patientmanagement system 200 may utilize other implantable devices as well thatprovide physiological measurements of the patient, such as drug pumps,neurological devices (e.g., stimulators), oxygen sensors, etc.

Derived measurements can also be determined from the implantabledevices. For example, a sleep sensor can rely on measurements taken byan implanted accelerometer that measures body activity levels. The sleepsensor can estimate sleeping patterns based on the measured activitylevels. Other derived measurements can include a functional capacityindicator, autonomic tone indicator, sleep quality indicator, coughindicator, anxiety indicator, and cardiovascular wellness indicator forcalculating a quality of life indicator for quantifying a patient'soverall health and well-being.

Devices 202, 204, and 206 can also be external devices, or devices thatare not implanted in the human body, that may be used to measurephysiological data. Such devices may include a multitude of devices tomeasure data relating to the human body, including temperature (e.g., athermometer), blood pressure (e.g., a sphygmomanometer), bloodcharacteristics (e.g., glucose levels), body weight, physical strength,mental acuity, diet, heart characteristics, and relative geographicposition (e.g., a Global Positioning System (“GPS”)).

Devices 202, 204, and 206 can also be environmental sensors. The devicescan be placed in a variety of geographic locations (in close proximityto patient or distributed throughout a population) and can recordnon-patient specific characteristics such as, for example, temperature,air quality, humidity, carbon monoxide level, oxygen level, barometricpressure, light intensity, and sound.

One or more of the devices 202, 204, and 206 (for example, device 206)may be external devices that measure subjective or perceptive data fromthe patient. Subjective data is information related to a patient'sfeelings, perceptions, and/or opinions, as opposed to objectivephysiological data. For example, the “subjective” devices can measurepatient responses to inquiries such as “How do you feel?” and “How isyour pain?” and “Does this taste good?”. The device can prompt thepatient and record subjective data from the patient using visual and/oraudible cues. For example, the patient can press coded response buttonsor type an appropriate response on a keypad. Alternatively, subjectivedata may be collected by allowing the patient to speak into a microphoneand using speech recognition software to process the subjective data.

In one example embodiment, the subjective device presents the patientwith a relatively small number of responses to each question posed tothe patient. For example, the responses available to the patient mayinclude three faces representing feelings of happiness, nominalness, andsadness. Averaged over time, a trend of a patient's well being mayemerge with a finer resolution than the quanta of the three responses.

The subjective data can be collected from the patient at set times, or,alternatively, can be collected whenever the patient feels likeproviding subjective data. The subjective data can also be collectedsubstantially contemporaneously with physiological data to providegreater insight into overall patient wellness.

The device 206 can be any device that accepts input from a patient orother concerned individual and/or provides information in a format thatis recognizable to the patient. Device 206 can typically include akeypad, mouse, display, handheld device, interactive TV, a cellulartelephone or other radio frequency (“RF”) communications device,cordless phone, corded phone, speaker, microphone, email message, andphysical stimulus such as an electric shock or change in temperature orlight intensity.

In one example embodiment, the device 206 includes or is part of acomputer system 300, as illustrated in FIG. 3. The computer system 300can include a central processor unit 312 and a system memory 314. Thecomputer system 300 further includes one or more drives 323 for readingdata from and writing data to, as well as an input device 344 such as akeyboard or mouse and a monitor 352 or other type of display device.

A number of program modules may be stored on the drive 323, including anoperating system 336, one or more application programs 338, otherprogram modules 340, and program data 342. The computer system 300 mayoperate in a networked environment using logical connections to one ormore remote computers or computer systems 356. Computer system 300 mayalso comprise a hand-held computer such as a personal digital assistant(“PDA”) computer.

Referring now to FIG. 4A, the advanced patient management system 200 mayinclude one or more interrogator/transceiver units (“ITUs”), such as ITU208. The ITU 208 includes an interrogator module 252 for receiving datafrom a device such as devices 202, 204, and 206, a memory module 254 forstoring data, a transceiver module 256 for sending data both to thedevices 202, 204, and 206 as well as other components of the advancedpatient management system 200. The ITU 208 also includes a power module258 that provides power.

The ITU 208 may perform one or more of the following functions: (1) datastorage; (2) data analysis; (3) data forwarding; (4) patientinteraction; and (5) patient feedback. For example, the ITU 208 mayfacilitate communications between the devices 202, 204, and 206 and thecommunications system 210. The ITU 208 can, periodically or inreal-time, interrogate and download into memory clinically relevantpatient data from the devices 202, 204, and/or 206. This data caninclude, in the cardiac sensor context, for example, P and R-Wavemeasurements, pacing, shocking events, lead impedances, pacingthresholds, battery voltage, capacitor charge times, ATR episodes withelectrograms, tachycardia episodes with electrograms, histograminformation, and any other clinical information necessary to ensurepatient health and proper device function. The data may be sent to theITU 208 by the devices 202, 204, and 206 in real-time or periodicallyuploaded out of buffers on the devices.

The ITU 208 may also allow for patient interaction. For example, the ITU208 may include a patient interface and allow the patient to inputsubjective data. In addition, the ITU 208 may provide feedback to thepatient based on the data that has been analyzed or based on informationcommunicated by the communications system 210.

In another embodiment, the ITU 208 can include a telemetry link from theimplanted device to a network that forms the basis of a wireless LAN inthe patient's home. The device can systematically download informationfrom the devices 202, 204, and 206 while the patient is sleeping, forexample. The data can be transmitted by landline or wirelessly to thecommunications system 210 or directly to the host 212. In addition, inone embodiment the ITU 208 can function in a hybrid form, utilizingwireless communication when available and defaulting to landlinecommunication when the wireless communication becomes unavailable.

Some devices, such as legacy implanted cardiac rhythm management (“CRM”)devices, communicate via an internal telemetry transceiver thatcommunicates with an external programmer. The communication range ofsuch devices is typically 4-12 inches. Communications system 210 mayinclude a special purpose “ITU” that communicates with an implantedlegacy device, on one hand, and communicates with the wireless Interneton the other. Patients with legacy devices are provided with these ITUsand are instructed to use them periodically (e.g., monthly).

The ITU 208 may be in the form of a small device that is placed in aninconspicuous place within the patient's residence. Alternatively, theITU may be implemented as part of a commonly used appliance in thepatient's residence. For example, the ITU may be integrated with analarm clock that is positioned near the patient's bed. In anotherembodiment, the ITU may be implemented as part of the patient's personalcomputer system. Other embodiments are also possible.

In another embodiment, the ITU 208 may comprise a hand-held device suchas a PDA, cellular telephone, or other similar device that is inwireless communication with the devices 202, 204, and 206. The hand-helddevice may upload the data to the communications system 210 wirelessly.Alternatively, the hand-held device may periodically be placed in acradle or other similar device that is configured to transmit the datato the communications system 210.

The ITU 208 can also perform analysis on the data and provide immediatefeedback, as well as perform a variety of self-diagnostic tests toverify that it is functioning properly and that communication with thecommunications system 210 has not be compromised. For example, the ITU208 can perform a diagnostic loop-back test, which involves sending arequest through the communications system 210 to the host 212. The host212 can then reply with a response back through the communicationssystem 210 to the ITU 208. If a specific duration elapses before the ITU208 receives the response, or if the ITU 208 receives an unexpectedresponse, the ITU 208 can provide indications that the system is notfunctioning properly. For example, if wireless communications betweenthe ITU 208 and the communications system 210 have been interrupted, andthe ITU 208 performs a self-diagnostic test that fails, the ITU 208 mayalert data management service personnel so that corrective action may betaken. Alternatively, the ITU 208 can sound a visual and/or audiblealarm to alert the patient that communication has been interrupted. Inanother embodiment, the ITU 208 can automatically fail-back to alandline system to communicate with the communications system 210.

In other embodiments of the advanced patient management system 200, theITU 208 can be eliminated completely, and the devices 202, 204, and 206can communicate directly with the communications system 210 and/or host212. For example, device 202 may include a miniature cellular phonecapable of wirelessly uploading clinical data from the device on aperiodic basis. This is particularly advantageous for devices that aremobile (e.g., an implanted device in a patient that is traveling). Thedevice 202 can incorporate wireless telecommunications such as cellular,BLUETOOTH, or IEEE 802.11B to communicate with the communications system210.

To conserve the energy of the devices 202, 204, and 206, particularlywhen the devices (e.g., device 202) are configured to communicatedirectly with the communications system 210 without using an ITU, in oneexample embodiment the devices are configured to communicate during agiven duty cycle. For example, the device 202 can be configured tocommunicate with the communications system 210 at given intervals, suchas once a week. The device 202 can record data for the time period(e.g., a week) and transmit the data to the communications system 210during the portion of the cycle that transmission is active and thenconserve energy for the rest of the cycle. In another example, thedevice 202 conserves energy and only communicates with thecommunications system 210 when an “interesting” event, such as a heartarrhythmia, has occurred. In this manner, device 202 can communicatedirectly with the communications system 210 and/or host 212 withoutusing the ITU 208, while conserving the energy of the device bycommunicating only during a given duty cycle.

If multiple devices, such as devices 202, 204, and 206, are provided fora given patient, each device may include its own means for communicatingwith the ITU 208 or communications system 210. Alternatively, a singletelemetry system may be implemented as part of one of the devices, orseparate from the devices, and each device 202, 204, and 206 can usethis single telemetry system to communication with the ITU 208 or thecommunications system 210.

In yet another embodiment, the devices 202, 204, and 206 include wiresor leads extending from devices 202, 204, and 206 to an area external ofthe patient to provide a direct physical connection. The external leadscan be connected, for example, to the ITU 208 or a similar device toprovide communications between the devices 202, 204, and 206 and theother components of the advanced patient management system 200.

The advanced patient management system 200 can also involve a hybrid useof the ITU 208. For example, the a device such as devices 202, 204, and206 can intelligently communicate via short-range telemetry with the ITUwhen the patient is located within the patient's home and communicatedirectly with the communications system 210 or host 212 when the patientis traveling. This may be advantageous, for example, to conserve batterypower when the devices are located near an ITU.

Communications system 210 provides for communications between and amongthe various components of the advanced patient management system 200,such as the devices 202, 204, and 206, host 212, and remote peripheraldevices 209. FIG. 4B illustrates communications system 210 according oneembodiment of the present invention. The communications system 210includes a plurality of computer systems 304, 306, 308, and 310, as wellas device 202, host 212, and remote peripheral device 109, connect toone another by the communications network 300. The communicationsnetwork 300 may be, for example, a local area network (“LAN”), wide areanetwork (WAN), or the Internet. Communications among the variouscomponents, as described more fully below, may be implemented usingwired or wireless technologies.

In the example embodiment illustrated, the host 212 includes servercomputers 318 and 322 that communicate with computers 304, 306, 308, and310 using a variety of communications protocols, described more fullybelow. The server computers 318 and 322 may store information indatabases 316 and 320. This information may also be stored in adistributed manner across one or more additional servers.

As shown in FIG. 4B, a variety of communication methods and protocolsmay be used to facilitate communication between devices 202, 204, and206, ITU 208, communications system 210, host 212, and remote peripheraldevice 109. For example, wired and wireless communications may be used.Wired communication methods may include, for example and withoutlimitation, traditional copper-line communications such as DSL,broadband technologies such as ISDN and cable modems, and fiber optics,while wireless communications may include cellular, satellite, radiofrequency (“RF”), Infrared, etc.

For any given communication method, a multitude of standard and/orproprietary communication protocols may be used. For example and withoutlimitation, wireless (e.g., radio frequency pulse coding, spreadspectrum, direct sequence, time-hopping, frequency hopping, etc.) andother communication protocols (e.g., SMTP, FTP, TCP/IP) may be used.Other proprietary methods and protocols may also be used. Further, acombination of two or more of the communication methods and protocolsmay also be used.

The various communications between the components of the advancedpatient management system 200 may be made securely using severaldifferent techniques. For example, encryption and/or tunnelingtechniques may be used to protect data transmissions. Alternatively, apriority data exchange format and interface that are kept confidentialmay also be used. Authentication can be implemented using, for example,digital signatures based on a known key structure (e.g., PGP or RSA).Other physical security and authentication measures may also be used,such as security cards and biometric security apparatuses (e.g., retinascans, iris scans, fingerprint scans, veinprint scans, voice, facialgeometry recognition, etc.). Conventional security methods such asfirewalls may be used to protect information residing on one or more ofthe storage media of the advanced patient management system 200.Encryption, authentication and verification techniques may also be usedto detect and correct data transmission errors.

Communications among the various components of the advanced patientmanagement system 200 may be enhanced using compression techniques toallow large amounts of data to be transmitted efficiently. For example,the devices 202, 204, and 206 may compress the information recorded fromthe patient prior to transmitting the information to the ITU 208 ordirectly to the communications system 210. The communication methods andprotocols can facilitate periodic and/or real-time delivery of data.

The host 212 may include a database module 214, an analysis module 216,and a delivery module 218 (shown in FIG. 2). The host 212 preferablyincludes enough processing power to analyze and process large amounts ofdata collected from each patient, as well as to process statistics andperform analysis for large populations. For example, the host 212 mayinclude a mainframe computer or multi-processor workstation. The host220 may also include one or more commercial personal computer systemscontaining sufficient computing power and memory. The host 220 mayinclude storage medium (e.g. hard disks, optical data storage devices,etc.) sufficient to store the massive amounts of high-resolution datathat are collected from the patients and analyzed.

The host 212 may also include identification and contact information(e.g., IP addresses and/or telephone numbers) for the various devicescommunicating with it, such as ITU 208 and peripheral device 209. Forexample, each ITU 208 may be assigned a hard-coded or static identifier(e.g., IP address, telephone number, etc.), which would allow the host212 to identify which patient's information the host 212 is receiving ata given instant. Alternatively, each device 202, 204, and 206 may beassigned a unique identification number, or a unique patientidentification number may be transmitted with each transmission ofpatient data.

When a device is first activated, several methods may be used toassociate data received by the advanced patient management system 200with a given patient. For example, each device may include a uniqueidentification number and a registration form that may be filled out bythe patient, caregiver, or field representative. The registration formcan be used to collect the necessary information to associate collecteddata with the patient. Alternatively, the user could logon to a web siteto allow for the registration information to be collected. Anotherpossible method involves including a barcode on each device that can bescanned prior to or in conjunction with initial measurements to provideinformation to associate the recorded data with the given patient.

Referring again to FIG. 2, the database module 214 can include a patientdatabase 400, a population database 402, a medical database 404, and ageneral database 406, all described further below. The patient database400 includes patient specific data, including data acquired by thedevices 202, 204, and 206. The patient database 400 can also include apatient's medical records. The patient database 400 can includehistorical information regarding the devices 202, 204, and 206. Forexample, if device 202 is an ICD, the patient database 400 can recordthe following device information: P and R measurements, pacingfrequency, pacing thresholds, shocking events, recharge time, leadimpedance, battery voltage/remaining life, ATR episode and EGMs,histogram information, and other device information. The informationstored in the database 400 can be recorded at various times depending onthe patient requirements or device requirements. For example, thedatabase 400 can be updated at periodic intervals that coincide with thepatient downloading data from the device. Alternatively, data in thedatabase 400 can be updated in real time. Typically, the samplingfrequency will depend on the health condition being monitored and theco-morbidities.

The population database 402 includes non-patient specific data, such asdata relating to other patients and population trends. The populationdatabase 402 also records epidemic-class device statistics and patientstatistics. The population database 402 also includes data relating tostaffing by health care providers, environmental data, pharmaceuticals,etc.

The medical database 404 includes clinical data relating to thetreatment of diseases. For example, the medical database 404 can includehistorical trend data for multiple patients in the form of a record ofprogression of their disease(s) along with markers of key events.

The general database 406 includes non-medical data of interest to thepatient. This can include information relating to news, finances,shopping, technology, entertainment, and sports. The general database406 can be customized to provide general information of specificinterest to the patient. For example, stock information can be presentedalong with the latest health information as detected from the devices202, 204, and 206.

In another embodiment, information may also be provided from an externalsource such as external database 558. For example, the external databasemay include external medical records maintained by a third party, suchas drug prescription records maintained by a pharmacy providinginformation related to what types of drugs have been prescribed for apatient. The analysis module 216 includes a patient analysis module 550,device analysis module 552, population analysis module 554, and learningmodule 556.

The patient analysis module 550 may utilize information collected by theadvanced patient management system 200, as well as information for otherrelevant sources, to analyze data related to a patient and providetimely and predictive assessments of the patient's well-being. Inperforming this analysis, the patient device module 550 may utilize datacollected from a variety of sources, include patient specificphysiological and subjective data collected by the advanced patientmanagement system 200, medical and historical records (e.g., lab testresults, histories of illnesses, etc., drugs currently and previouslyadministered, etc.), as well as information related to population trendsprovided from sources external to the advanced patient management system200.

For example, in one embodiment, the patient analysis module 550 may makea predictive diagnosis of an oncoming event based on information storedin the database module 214. For example, the data continuously gatheredfrom a device of a given patient at a heightened risk for a chronicdisease event (such as de-compensations in heart failure) can beanalyzed. Based on this analysis, therapy, typically device-based orpharmaceutical, can then be applied to the patient.

In another example embodiment, the patient analysis module 550 mayprovide a diagnosis of patient health status and predicted trend basedon present and recent historical data collected from a device asinterpreted by a system of expert knowledge derived from workingpractices within clinics. For example, the patient analysis module 550may perform probabilistic calculations using currently collectedinformation combined with regularly collected historical information topredict patient health degradation.

In another example embodiment, the patient analysis module 550 mayconduct pre-evaluation of the incoming data stream combined with patienthistorical information and information from patients with similardisease states. The pre-evaluation system is based on data derived fromworking clinical practices and the records of outcomes. The derived datacan be processed into a neural network or equivalent system to reflectthe clinical practice. Further, the patient analysis module 550 may alsoprovide means for periodic processing of present and historical data toyield a multidimensional health state indication along with diseasetrend prediction, next phase of disease progression co-morbidities, andinferences about what other possible diseases may be involved. Thepatient analysis module 550 may also integrate data collected frominternal and external devices with subjective data to optimizemanagement of overall patient health.

The device analysis module 552 analyzes data from the devices 202, 204,and 206 and ITU 208 to predict and determine device failures. Forexample, if an implanted device 202 fails to communicate at an expectedtime, device analysis module 552 determines the source of the failureand takes action to restore the performance of the device 202.

The device analysis module 552 may also perform additional deterministicand probabilistic calculations. For example, the device analysis module552 may gather data related to charge levels within a given device, suchas an ICD, and provide analysis and alerting functions based on thisinformation if, for example, the charge level reaches a point at whichreplacement of the device and/or battery is necessary. Similarly, earlydegradation or imminent failure of implanted devices can be identifiedand proactively addressed, or at-risk devices can be closely monitored.

The population analysis module 554 uses the data collected in thedatabase module 214 to manage the health of a population. For example, aclinic managing cardiac patients can access the advanced patientmanagement system 200 and thereby obtain device-supplied advanceinformation to predict and optimize resource allocation both as toimmediate care and as a predictive metric for future need of practicingspecialists. As another example, the spread of disease in remotepopulations can be localized and quarantined rapidly before furtherspread.

In one embodiment, population analysis module 554 trends the patientpopulation therapy and management as recorded by the devices and directshealth care resources to best satisfy the needs of the population. Theresources can include people, facilities, supplies, and/orpharmaceuticals. In other embodiments, the population analysis modulecan detect epidemics and other events that affect large populationgroups. The population analysis module 554 can issue alerts that caninitiate a population quarantine, redirect resources to balance size ofstaffing with number of presenting population, and predict future needof qualified specialists.

The population analysis module 554 may utilize a variety ofcharacteristics to identify like-situated patients, such as, forexample, sex, age, genetic makeup, etc. The population analysis module554 may develop large amounts of data related to a given populationbased on the information collected by the advanced patient managementsystem 200. In addition, the population analysis module 554 mayintegrate information from a variety of other sources. For example, thepopulation analysis module 554 may utilized data from public domaindatabases (e.g. National Institute of Health), public and governmentaland health agency databases, private insurance companies, medicalsocieties (e.g. American Heart Association), and genomic records (e.g.,DNA sequences).

In one embodiment of the invention, the host 212 may be used as a “dataclearinghouse,” to gather and integrate data collected from the devices202, 204, and 206, as well as data from sources outside the advancedpatient management system 200. The integrated data can be shared withother interested entities, subject to privacy restrictions, therebyincreasing the quality and integration of data available.

The learning module 556 analyzes the data provided from the variousinformation sources, including the data collected by the advancedpatient system 200 and external information sources. For example, thelearning module 556 analyzes historical symptoms, diagnoses, andoutcomes along with time development of the diseases and co-morbidities.The learning module 556 can be implemented via a neural network (orsimilar) system.

The learning module 556 can be partially trained (i.e., the learningmodule 556 may be implemented with a given set of preset values and thenlearn as the advanced patient management system functions) or untrained(i.e., the learning module 556 is initiated with no preset values andmust learn from scratch as the advanced patient management systemfunctions). In other alternative embodiments, the learning module 556may continue to learn and adjust as the advanced patient managementsystem functions (i.e., in real time), or the learning module 556 mayremain at a given level of learning and only advanced to a higher levelof understanding when manually allowed to do so.

The learning module 556 may implement various algorithms andmathematical modeling such as, for example, trend and statisticalanalysis, data mining, pattern recognition, cluster analysis, neuralnetworks and fuzzy logic. Learning module 556 may perform deterministicand probabilistic calculations. Deterministic calculations includealgorithms for which a clear correlation is known between the dataanalyzed and a given outcome. For example, there may be a clearcorrelation between the power left in a battery of an implantable deviceand the amount of time left before the battery must be replaced.

A probabilistic calculation involves the correlation between data and agiven outcome that is less than 200 percent certain. Probabilisticdeterminations require an analysis of several possible outcomes and anassignment of probabilities for those outcomes (e.g., an increase inweight of a patient may, at a 25% probability, signal an impendingde-compensation event and/or indicate that other tests are needed). Thelearning module 556 may perform probabilistic calculations and select agiven response based on less than a 100% probability. Further, as thelearning module 556 “learns” for previous determinations (e.g., througha neural network configuration), the learning module 556 may become moreproficient at assigning probabilities for a given data pattern, therebybeing able to more confidently select a given response. As the amount ofdata that has been analyzed by the learning module 556 grows, thelearning module 556 may become more and more accurate at assigningprobabilities based on data patterns. A bifurcated analysis may beperformed for diseases exhibiting similar symptoms.

In addition, patient specific clinical information can be stored andtracked for hundreds of thousands of individual patients, enabling afirst-level electronic clinical analysis of the patient's clinicalstatus and an intelligent estimate of the patient's short-term clinicalprognosis. The learning module 556 may be capable of tracking andforecasting a patient's clinical status with increasing levels ofsophistication by measuring a number of interacting co-morbidities, allof which may serve individually or collectively to degrade the patient'shealth. This will enable learning module 556, as well as caregivers, toformulate a predictive medical response to oncoming acute events in thetreatment of patients with chronic diseases such as heart failure,diabetes, pain, cancer, and asthma/COPD, as well as possibly head-offacute catastrophic conditions such as MI and stroke.

In a neural network embodiment, new clinical information is presented tocreate new neural network coefficients that are distributed as a neuralnetwork knowledge upgrade. The learning module 556 can include a modulefor verifying the neural network conclusions for clinical accuracy andsignificance. The learning module 556 can analyze a database of testcases, appropriate outcomes and relative occurrence of misidentificationof the proper outcomes. In some embodiments, the learning module 556 canupdate the analysis module 216 when the analysis algorithms exceed athreshold level of acceptable misidentifications.

The delivery module 218 coordinates the delivery of feedback based onthe analysis performed by the host 212. In response to the analysismodule 216, delivery module 218 can manage the devices 202, 204, and206, perform diagnostic data recovery, program the devices, andotherwise deliver information as needed.

In some embodiments, the delivery module 218 can manage a web interfacethat can be accessed by patients or caregivers. The information gatheredby an implanted device can be periodically transmitted to a web sitethat is securely accessible to the caregiver and/or patient in a timelymanner. In other embodiments a patient accesses detailed healthinformation with diagnostic recommendations based upon analysisalgorithms derived from leading health care institutions.

For example, the caregiver and/or patient can access the data andanalysis performed on the data by accessing one or more general contentproviders. In one example, the patient's health information is accessedthrough a general portal such as MY YAHOO provided by YAHOO! INC. ofSunnyvale, Calif. A patient can access his or her MY YAHOO homepage andreceive information regarding current health and trends derived from theinformation gathered from the devices 202, 204, and 206, as well asother health information gathered from other sources. The patient mayalso access information other than health information on the MY YAHOOwebsite, such as weather and stock market information. Other electronicdelivery methods such as email, facsimile, etc. can also be used.

In an alternative embodiment, the data collected and integrated by theadvanced patient system 200, as well as any analysis performed by thesystem 200, can be delivered by delivery module 218 to a caregiver'shospital computer system for access by the caregiver. A standard orcustom interface can facilitate communications between the advancedpatient management system 200 and a legacy hospital system used by thecaregiver so that the caregiver can access all relevant informationusing a system familiar to the caregiver.

In addition, the advanced patient management system 200 can beconfigured so that various components of the system (e.g., ITU 208,communications system 210, and/or host 212) provide reporting to variousindividuals (e.g., patient and/or caregiver). For example, differentlevels of reporting can be provided by (1) the ITU 208 and (2) the host212. For example, the ITU 208 may be configured to conduct rudimentaryanalysis of data gathered from devices 202, 204, and 206, and providereporting should an acute situation be identified. For example, if theITU 208 detects that a significant heart arrhythmia is imminent orcurrently taking place, the ITU 208 can provide reporting in the form ofan audible or visual alarm.

The host 212 can provide a more sophisticated reporting system. Forexample, the host 212 may provide exception-based reporting and alertsthat categorize different reporting events based on importance. Somereporting events may not require caregiver intervention and thereforecan be reported automatically. In other escalating situations, caregiverand/or emergency response personnel may need to become involved. Forexample, based on the data collected by the advanced patient managementsystem 200, the delivery module 218 can communicate directly with thedevices 202, 204, and 206, contact a pharmacy to order a specificmedication for the patient, and/or contact 911 emergency response. In analternative embodiment, the delivery module 218 and/or the patient mayalso establish a voice communication link between the patient and acaregiver, if warranted.

In addition to forms of reporting including visual and/or audibleinformation, the advanced patient management system 200 can alsocommunicate with and reconfigure one or more of the devices 202, 204,and 206. For example, if device 202 is part of a cardiac rhythmmanagement system, the host 212 and communicate with the device 202 andreconfigure the therapy provided by the cardiac rhythm management systembased on the data collected from one or more of the devices 202, 204,and 206. In another embodiment, the delivery module 218 can provide tothe ITU 208 recorded data, an ideal range for the data, a conclusionbased on the recorded data, and a recommended course of action. Thisinformation can be displayed on the ITU 208 for the patient to review.

The advanced patient management system 200 may also include one or moreremote peripheral devices 209. The remote peripheral device 209 mayinclude, for example and without limitation, cellular telephones,pagers, PDA devices, facsimiles, remote computers, printers, videoand/or audio devices, etc. The remote peripheral device 209 maycommunicate using landline or wireless technologies and may be used bythe patient or caregiver to communicate with the communications system210 and/or the host 212. For example, the remote peripheral device 209may be used by a caregiver to receive alerts from the host 212 based ondata collected from the patient and to send instructions from thecaregiver to either the patient or other clinical staff. In anotherexample, the remote peripheral device 209 may be used by the patient toreceive periodic or real time updates and alerts regarding the patient'shealth and well-being.

Referring now to FIG. 5, an illustrative hardware architecture for aninterface device 99 will be described. As described briefly above withrespect to FIG. 1A, the interface device 99 comprises a wirelesscommunication device capable of communicating with a host computer 200via a long range communications link 104 and of communicating with anIMD 100 via a short range communications link 103. More particularly,according to the embodiment of the invention described herein, theinterface device 99 comprises a digital wireless telephone modified forcommunication with the IMD 100 and for communicating with the hostcomputer 200.

In order to provide these functions, the interface device 99 comprises acommand and control processor 516 for controlling the operation of theinterface device 99. As known to those skilled in the art, the commandand control processor 516 may be embodied by any of a number of centralprocessing unit devices. A memory 522 is used in conjunction with thecommand and control processor 516. The memory 522 stores a number ofapplication and data files utilized for communicating with the hostcomputer 200 and the IMD 100.

In particular, the memory 522 stores a phone application 524. The phoneapplication 524 controls the operation of the interface device 99 whenthe device is utilized as a conventional wireless telephone. In thismanner, the interface device 99 may be utilized to send and receivecalls in a conventional manner through the long range wirelesscommunications link 104. Aspects of the phone application 524 are wellknown to those skilled in the art.

The memory 522 also comprises an IMD interface application 526. The IMDinterface application 526 is a time-sliced software application thatexecutes concurrently with the phone application 524. As will bedescribed in greater detail below with reference to FIG. 6, the IMDinterface application 526 provides functionality for communicating withthe IMD 100, interrogating the IMD 100 for clinical data, and fortransmitting the clinical data received from the IMD 100 to the hostcomputer 200 via the long range communications link 104. The IMDinterface application 526 is described in detail below with reference toFIG. 6.

The memory 522 also includes IMD support files 528. The IMD supportfiles 528 describe communication protocols for communicating withdifferent types of IMD 100 devices. In this manner, the interface device99 may be programmed to communicate with previously released IMD devices100 and IMDs 100 to be released in the future. The particular IMDsupport file to be utilized with a given IMD 100 may be selected throughthe keypad 504 and the display 502, or through the use of an externalprogrammer.

The memory 522 also stores an IMD serial number 530. The IMD serialnumber 530 comprises a hardware serial number for the IMD 100. The IMDserial number 530 may be utilized by the interface device 99 for gainingsecure access to the memory contents of the IMD 100. Moreover, by keyingthe IMD serial number 530 to a hardware serial number of the IMD 100, asecure interface can be provided between the interface device 99 and theIMD 100. Other interface devices 99 not having the proper serial numberfor gaining access to the IMD 100 would not be permitted to engage inany form of communication with the IMD 100.

The memory 522 also stores IMD data 531. IMD data 531 comprises datareceived from the IMD 100. This data may include data regarding thecharacteristics of the patient's 102 body and data regarding theoperation of the IMD 100. As used herein, the term “clinical data”refers to both data describing the physical condition of the patient 102and data describing the operation of the IMD 100.

The hardware architecture of the illustrative interface device 99 alsocomprises a transmitter/receiver unit 520. The transmitter/receiver unit520, or transceiver, comprises a frequency and protocol agiletransmitter and receiver unit. The transceiver 520 is capable ofconfiguring itself for communication with the IMD 100 via the shortrange communications link 102. The transceiver 520 is also capable ofconfiguring itself for communications with the host computer 200 via thelong range communication link 104. Moreover, in the embodiment of theinvention described herein, the transceiver 520 is capable ofconfiguring itself for voice communication with a wireless telephonenetwork over the long range communications link 104. It should beappreciated that the function of the transceiver 520 may be performed byother types of devices.

Configuration of the transceiver 520 is performed under control of theIMD interface application 526. As will be described in greater detailbelow with respect to FIG. 6, the IMD interface application 526 mayconfigure the transceiver 520 for communication with the IMD 100 on apredetermined schedule. Once the transceiver 520 has been configured forcommunication with the IMD 100, the IMD interface application 526 mayinterrogate the IMD 100 for stored clinical data. The clinical datareceived from the IMD 100 may then be stored as IMD data 531 in thememory 522. Once the clinical data has been received from the IMD 100,the IMD interface application 526 may reconfigure the transceiver 520for use via the long range communications link 104.

The IMD interface application 526 is also operative to periodicallydetermine whether IMD data 531 is stored in the memory 522 that has notbeen transmitted to the host computer 200. If the IMD interfaceapplication 526 makes such a determination, the IMD interfaceapplication 526 is further operative to establish a connection betweenthe interface device 99 and the host computer 200 over the long rangecommunications link 104. The IMD data 531 may then be transmitted fromthe interface device 99 to the host computer 200. If the IMD data 531 issuccessfully transmitted to the host computer 200, the IMD interfaceapplication 526 may remove the stored IMD data 531 from the memory 522.A schedule may be coordinated between the interface device 99 and thehost computer 200 for providing a predetermined time at which the IMDdata 531 should be transmitted.

The interface device 99 also includes a baseband processor 514 forsetting up the long range communications link 104. As known to thoseskilled in the art, the baseband processor 514 is responsible fornegotiating frequencies with the MTSO 110 and otherwise maintaining thecommunications link for voice and data communications over the longrange communications link 104.

The interface device 99 also includes a keypad 504 for providing inputto the interface device 99 and a display 502 for generating output. Theinterface device 99 also includes a microphone 506 and a speaker 508 foruse during voice calls over the long range communications link 104. Ananalog-to-digital converter 510 and a digital-to-analog converter 512are also provided as a part of the interface device 99 for convertingspoken signals to digital data and for converting digital data to analogsignals that may be played back on the speaker 508, respectively. Otherconventional components may be provided as part of the interface device99 for enabling voice and digital data communication over the long rangecommunication link 104.

Referring now to FIG. 6, a state machine 600 will be describedillustrating the operation of the interface device 99. The state machine600 begins in a home state 602, where the interface device 99 operatesas a digital wireless telephone. As mentioned above, according to theembodiment of the present invention described herein, the interfacedevice 99 comprises a digital wireless telephone modified forcommunication with the IMD 100 and the host computer 200. However, itshould be appreciated by those skilled in the art that the interfacedevice 99 may comprise other types of wireless digital devices such astwo-way pagers and the like capable of communicating over a wirelesscommunications network with a host computer 200.

At the home state 602, the interface device 99 is operative to send andreceive wireless telephone calls over the long range telecommunicationslink 104. The interface device 99 is also operative to provide othertypes of conventional features provided by a wireless digital telephone.While in the home state 602, the interface device 99 is also operativeto periodically interrogate the IMD 100 under control of the IMDinterface application 526. The interrogation of the IMD 100 by theinterface device 99 may occur according to a predefined schedulecoordinated with the IMD 100, or other type of schedule set by a user.When the appointed time for interrogating the IMD 100 occurs, the statemachine 600 transitions from state 602 to state 604.

At state 604, the IMD interface application 526 reconfigures thetransceiver 520 for communication with the IMD 100 via the short rangecommunication link 103. As a result, the interface device 99 isincapable of communicating via the long range communications link 104while the IMD 100 is being interrogated. According to another embodimentof the invention, two transceivers are provided, with one beingdedicated to communicating with the IMD 100 and another dedicated towireless digital communication via the long range communication link104. In this manner, communications over the long range communicationlink 104 may take place concurrently with the interrogation of the IMD100.

From state 604, the state machine 600 transitions to state 606, wherethe IMD 100 is unlocked. An authentication procedure may be utilized bythe interface device 99 to unlock and communicate with the IMD 100 in asecure manner. For instance, the IMD serial number 530 may becommunicated to the IMD 100 to authenticate the interface device 99 forcommunication. Once the IMD 100 has been unlocked, the state machine 600transitions to state 608.

At state 608, the interface device 99 interrogates the IMD 100 forclinical data stored within the IMD 100. The state machine 600 thentransitions to state 610 where the clinical data received from the IMD100 is stored within the memory 522 as IMD data 531. If additional dataremains to be received within the IMD 100, the state machine 600transitions back to state 608 where the interface device 99 continues tointerrogate the IMD 100. Once all the clinical data residing within theIMD 100 has been received by the interface device 99, the state machine600 transitions to state 612.

At state 612, the IMD 100 is locked in a secure manner by the interfacedevice 99. The state machine 600 then transitions to state 614, wherethe transceiver 520 is reconfigured by the IMD interface application 526for communication over the long range communications link 104. In thismanner, the interface device 99 is reconfigured for digital voice anddata communications over the long range wireless link 104. The statemachine 600 then returns back to the home state 602 where normalwireless telephone operation is resumed.

From the home state 602, the interface device 99 also periodicallyestablishes a communications link with the host computer 200 fortransmission of the clinical data received from the IMD 100. Theinterface device 99 may transmit clinical data received from the IMD 100to the host computer 200 immediately after receiving the information ifthe clinical data concerns a serious medical condition or a malfunctionof the IMD 100. Alternatively, if the clinical data received from theIMD 100 is routine status data that does not relate to a serious medicalcondition or a malfunction, the interface device 99 may transmit theclinical data to the host computer 200 based upon a predeterminedschedule. The predetermined schedule may be based upon, among otherthings, the line charges for utilizing the long range communicationslink 104. For instance, the interface device 99 may wait until off-peakhours when airtime rates are low to transmit the clinical data to thehost computer 200. Those skilled in the art should appreciate that theschedule for communication between the interface device 99 and the hostcomputer 200 may also be based upon other types of factors.

If, at the home state 602, the interface device 99 determines that thememory 522 contains IMD data 531 that must be transmitted to the hostcomputer 200 immediately, the state machine 600 transitions to state616. At state 616, the interface device 99 establishes a communicationslink with the host computer 200 via the long range communications link104. The state machine 600 then transitions from state 616 to state 620where the stored IMD data 531 is transmitted to the host computer 200via the long range communications link 104. When the transmission hascompleted, the state machine 600 returns to the home state 602.

In order for a scheduled transmission to be made from the interfacedevice 99 to the host computer 200, the state machine 600 transitionsfrom state 602 to state 618. At state 618, the interface device 99determines whether the current time is a scheduled time to transmit theIMD data 531 to the host computer 200. If the current time is not ascheduled time to transmit the clinical data, the state machine 600returns to the home state 602. If, however, at state 618 the interfacedevice 99 determines that the current time is a scheduled time totransmit, the state machine 600 transitions to state 616. As describedabove, the interface device 99 establishes a communications link withthe host computer at state 616. The clinical data is then transmittedfrom the interface device 99 to the host computer 200 at state 620. Whenthe interface device 99 has completed the transmission of the clinicaldata, the state machine 600 returns to the home state 602, where normalwireless telephone operation resumes.

Referring now to FIG. 7, an interface device 105 will be describedaccording to another embodiment of the present invention. As describedbriefly above, in this embodiment of the present invention, theinterface device 105 is operative to provide an interface between an IMD100 and a host computer 200 through the use of a standard, unmodifiedwireless digital telephone 107. In order to provide such an interface,the interface device 105 comprises a transmitter/receiver unit 704, alsocalled a transceiver, capable of establishing a short rangecommunications link 103 with the IMD 100. Through the short rangecommunications link 103, the interface device 105 can interrogate theIMD 100 and retrieve clinical data stored within the IMD 100.

The transceiver 704 is operated under control of a central processingunit 702. A memory 708 is also provided that stores a program andsupport files for enabling communication between the IMD 100 and thehost computer 200. In particular, the memory 708 stores an IMD/phoneinterface application 710. The IMD/phone interface application 710controls the operation of the interface device 105. In particular, theIMD/phone interface application 710 controls communication with the IMD100 and the wireless digital telephone 107. Moreover, the IMD/phoneinterface application 710 controls the communication channel between theinterface device 105 and the host computer 200. Additional detailsregarding the operation of the IMD/phone interface application 710 aredescribed below with respect to FIG. 8.

The memory 708 also stores IMD support files 528, IMD serial number 530,and IMD data 531. As described above with respect to FIG. 5, the IMDsupport files 528 include data necessary to enable communicationsbetween any type of IMD 100 and the interface device 105. The datacontained within the IMD support files 528 includes data regarding theprotocols and communication frequencies utilized by different IMDs 100.The IMD serial number 530 may be used in an authentication procedure togain secure access to the data stored within the IMD 100. The IMD data531 comprises data retrieved from the IMD 100 by the interface device105. The IMD data 531 is also referred to herein as clinical data.

The interface device 105 also comprises an input/output (“I/O”)interface 706. The I/O interface 706 is connected to the centralprocessing unit 702 and provides an interface to the wireless digitaltelephone 107 and a computer 200A. The I/O interface 706 may provide aninterface to the wireless digital telephone 107 through a connection712. The connection 712 may comprise a serial connection, a USBconnection, or other type of connection utilized by wireless telephonemanufacturers.

The I/O interface 706 also provides a connection 714 to a computer 200A.The computer 200A may comprise a standard personal computer operative toexecute a programming application for configuring the interface device105 for use with a particular IMD 100. In particular, the computer 200Amay be utilized to select a particular IMD support file, to enter an IMDserial number 530, and to otherwise configure the interface device 105.The connection 714 between the I/O interface 706 and the computer 200Amay comprise a serial connection, a USB connection, a FIREWIREconnection, or other type of standard I/O connection known to thoseskilled in the art.

According to one actual embodiment of the present invention, theinterface device 105 is mechanically attached to the wireless digitaltelephone 107. The interface device 105 is configured in such a mannerthat it is conformal to the wireless digital telephone 107. In thismanner, the interface device 105 may be attached to the wireless digitaltelephone 107 and electrically connected through the connection 712.Moreover, the interface device 105 may be configured in a manner thatallows the wireless digital telephone 107 to be placed in a standardcharging cradle without modification. The interface device 105 may alsobe manufactured in a way that enables it to be semi-permanently attachedto the wireless digital telephone 107 and mechanically rugged.

Referring now to FIG. 8, a state machine 800 will be describedillustrating the operation of the interface device 105. As describedabove, the interface device 105 is operated by the central processingunit 702 in conjunction with the IMD/phone interface application 710.The IMD/phone interface application 710 begins operation in an idlestate 802. Periodically, the IMD/phone interface application 710 willestablish a short range communications link 103 with the IMD 100 andinterrogate the IMD 100. The interrogation may occur at a timepredetermined and scheduled between the interface device 105 and the IMD100. When the scheduled time for interrogation arrives, the statemachine 800 transitions to state 804 where the interface device 105unlocks the IMD 100. As described above, an authentication procedure maybe utilized to provide secure access to the IMD 100. Accordingly to oneembodiment of the present invention, the interface device 105 providesthe IMD serial number 530 to the IMD 100 to authenticate itself. If theIMD 100 is successfully unlocked by the interface device 105, the statemachine 800 transitions to state 806.

At state 806, the interface device 105 interrogates the IMD 100 toretrieve the clinical data stored within the IMD 100. In order tointerrogate the IMD 100, the transmitter/receiver unit 704 communicateswith the IMD 100 via the short range communications link 103. When datais received from the IMD 100, the state machine 800 transitions to state808. At state 808 the clinical data received from the IMD 100 is storedin the memory 708. If additional clinical data remains within the IMD100 to be retrieved, the state machine returns to state 806, where theinterface device 105 continues to interrogate the IMD 100. When all ofthe clinical data has been retrieved from the IMD 100, the state machine800 transitions to state 810 where the IMD 100 is locked. The statemachine 800 then returns back to the idle state 802.

From the idle state 802, the IMD/phone interface application 702periodically transmits IMD data 531 to the host computer 200 through thewireless digital telephone 107. The time for transmission of theclinical data from the interface device 105 to the host computer 200 maybe based on a schedule predetermined between the interface device 105and the host computer 200 or based upon the type of clinical data to bedelivered. For instance, clinical data relating to normally deliveredstatus information and noncritical patient information may be deliveredon a predetermined schedule. However, information relating to a criticalfailure of the IMD 100 or to a serious health condition encountered bythe patient 102 may be delivered immediately after it is retrieved fromthe IMD 100.

In order to transmit IMD data 531 from the interface device 105 to thehost computer 200, the state machine 800 transitions from the idle state802 to state 812. At state 812, the interface device 105 determinesthrough the I/O interface 706 whether the wireless digital telephone 107is currently in use. If the wireless digital telephone 107 is currentlyin use, the state machine 800 returns to the idle state 802. Theinterface device 105 may then wait a predetermined period of time beforeagain attempting to transmit the IMD data 531.

If, at state 812, the interface device 105 determines that the wirelessdigital telephone 107 is not in use, the state machine transitions tostate 814. At state 814, the interface device 105 initiates a connectionwith the host computer through the I/O interface 706, the connection712, and the wireless digital telephone 107. As described above, thewireless telephone 107 may utilize a long range wireless communicationslink 104 to establish communication with the host computer 200. Once thecommunications channel has been established, the state machine 800transitions to state 816.

At state 816, the clinical data stored within the interface device 105is transmitted to the host computer 200. Once the clinical data has beentransmitted from the interface device 105 to the host computer 200, theclinical data stored within interface 105 is deleted. The data deliveredto the host computer 200 may also include a telephone number for thewireless digital telephone 107 so that the patient management system maycontact a caregiver, emergency services, a physician, or the patient ifthe delivered data indicates a critical medical condition. From state816, the state machine 800 returns to the idle state 802.

Based upon the foregoing, it should be appreciated that the presentinvention provides methods and apparatus for enabling communicationbetween an IMD and a host computer. Although the invention has beendescribed in language specific to computer structural features,methodological acts and by computer readable media, it is to beunderstood that the invention defined in the appended claims is notnecessarily limited to the specific structures, acts or media described.Therefore, the specific structural features, acts and mediums aredisclosed as exemplary embodiments implementing the claimed invention.Since many embodiments of the invention can be made without departingfrom the spirit and scope of the invention, the invention resides in theclaims hereinafter appended.

1. An apparatus for enabling data communication between an implantablemedical device and a host computer, comprising: a frequency and protocolagile transceiver configured to communicate with the implantable medicaldevice via a short range wireless communications link in a first stateand to communicate with the host computer via a long range wirelesscommunications link in a second state; a central processing unit; amemory; and a program capable of executing on the central processingunit operative to periodically interrogate the implantable medicaldevice for clinical data in the first state.
 2. The apparatus of claim1, wherein the program, while interrogating the implantable medicaldevice, is configured to: unlock the implantable medical device; receivethe clinical data stored in the implantable medical device via the shortrange wireless communications link; determine whether clinical data isstored in the memory; in response to determining that clinical data isstored in the memory; establish the communications link with the hostcomputer via the communications device; and transmit the clinical datato the host computer.
 3. The apparatus of claim 1, wherein the programis configured to: configure the transceiver for communication with theimplantable medical device using the short range wireless communicationslink, receive clinical data from the implantable medical device usingthe short range wireless communications link, and store the clinicaldata in the memory for delivery to the host computer using the longrange wireless communications link.
 4. The apparatus of claim 3, whereinthe program is operative to: configure the transceiver for communicationwith the host computer using the long range wireless communicationslink; determine whether clinical data is stored in the memory; andestablish a data communications channel with the host computer using thelong range wireless communications link and to transmit the clinicaldata to the host computer using the channel if clinical data is storedin the memory.
 5. The apparatus of claim 4, wherein the program isoperative to: determine whether the clinical data was successfullytransmitted to the host computer; and remove the clinical data from thememory if the clinical data was successfully transmitted to the hostcomputer.
 6. The apparatus of claim 5, wherein the program is operativeto transmit the clinical data to the host computer on a schedulecoordinated with the host computer.
 7. The apparatus of claim 3, whereinthe program is operative to: configure the transceiver for communicationwith the host computer using the long range wireless communicationslink; determine whether the clinical data should be delivered to thehost computer if the clinical data is stored in the memory; andestablish a data communications channel with the host computer using thelong range wireless communications link and to transmit the clinicaldata to the host computer using the channel if clinical data should bedelivered to the host computer.
 8. A method comprising: periodicallyconfiguring a frequency and protocol agile transceiver to communicatewith an implantable medical device via a short range wirelesscommunications link; periodically interrogating the implantable medicaldevice for clinical data using the frequency and protocol agiletransceiver and the short range wireless communication link; configuringthe frequency and protocol agile transceiver to communicate with a hostcomputer via a long range wireless communications link; andcommunicating the clinical data to the host computer using the frequencyand protocol agile transceiver and the long range communication link. 9.The method of claim 8, further comprising: determining whether theclinical data should be delivered to the host computer at a particulartime; and transmitting the clinical data to the host computer using thelong range communication link if clinical data should be delivered tothe host computer at the particular time.
 10. The method of claim 9,further comprising: storing the clinical data for delivery if theclinical data should not be delivered to the host computer at theparticular time.
 11. The method of claim 10, further comprising:transmitting the stored clinical data to the host computer using thesecond wireless communications link on a schedule coordinated with thehost computer.
 12. The method of claim 8, including: storing a serialnumber corresponding to the implantable medical device; and transmittingthe serial number to the implantable medical device as part of anauthentication procedure.
 13. The method of claim 12, includingutilizing one or more implantable medical device support files thatdescribe protocols for communicating with a plurality of different typesof implantable medical devices to communicate with the implantablemedical device.
 14. A system comprising: an implantable medical device,capable of communicating data wirelessly; a host computer, capable ofstoring and communicating data; an apparatus, capable of communicatingwirelessly with both the implantable medical device and the hostcomputer, the apparatus comprising: a transceiver configured tocommunicate with the implantable medical device via a short rangewireless communications link in a first state and to communicate withthe host computer via a long range wireless communications link in asecond state; a central processing unit; a memory; and a program capableof executing on the central processing unit operative to periodicallyinterrogate the implantable medical device for clinical data in thefirst state.
 15. The system of claim 14, wherein the apparatus isconfigured to: store a serial number corresponding to the implantablemedical device; and transmit the serial number to the implantablemedical device as part of an authentication procedure.
 16. The system ofclaim 14, wherein the program is operable to store the clinical data inthe memory for delivery to the host computer using the long rangewireless communications link.
 17. The system of claim 16, wherein theprogram is operative to: reconfigure the transceiver from the firststate to the second state; determine whether the clinical data should bedelivered to the host computer if the clinical data is stored in thememory; establish a data communications channel with the host computerusing the long range wireless communications link; and to transmit theclinical data to the host computer using the channel if clinical datashould be delivered to the host computer.
 18. The system of claim 17,wherein the program is operative to: determine whether the clinical datawas successfully transmitted to the host computer; and remove theclinical data from the memory if the clinical data was successfullytransmitted to the host computer.
 19. The system of claim 18, whereinthe program is operative to: transmit the clinical data to the hostcomputer on a schedule coordinated with the host computer.
 20. Thesystem of claim 18, wherein the apparatus includes a cellular phone.